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Abstract:

A system for providing support to an anatomical structure of the pelvis
includes first and second soft tissue anchors, a suburethral support, an
introducer, and a filament. The first soft tissue anchor has a proximal
end and a distal end and includes a base having a hollow tubular
structure, a plurality of barbs, and a tip. The sub-urethral support
portion has first and second ends, the first and second soft tissue
anchors extending from the first and second ends of the sub-urethral
support portion. The introducer has an elongate shaft and a handle, the
elongate shaft having a proximal end at the handle and a distal end with
an aperture extending through the distal end. The filament extends
through the hollow tubular section of the first soft tissue anchor and
through the aperture in the distal end of introducer.

Claims:

1. A system for treating urinary incontinence by providing support to a
urethra of a patient, the system comprising: suburethral support formed
of a mesh material and being substantially rectangular in shape, the
suburethral support defining a first end portion and a second end
portion, the first end portion located opposite the second end portion; a
first soft tissue anchor coupled to the first end portion of the
suburethral support and a second soft tissue anchor coupled to the second
end portion of the suburethral support, the first soft tissue anchor
having a base, an apex opposite the base, and a plurality of barbs
adapted for soft tissue anchoring; a first filament connected to the base
of the first soft tissue anchor; and an introducer having an elongate
shaft and a handle, the elongate shaft having a distal portion and a
proximal portion, the elongate shaft being coupled at the proximal
portion to the handle, the distal portion of the elongate shaft defining
an aperture adapted to receive the first filament, the distal portion of
the elongate shaft having a terminal end adapted to engage with the first
soft tissue anchor such that the apex of the first soft tissue anchor
extends distal to the terminal end of the introducer.

2. The system of claim 1, wherein the first filament is attached around a
portion of the base of first soft tissue anchor.

3. The system of claim 1, further comprising a second filament connected
to the base of the second soft tissue anchor.

4. The system of claim 1, wherein the terminal end of the distal portion
of the elongate shaft is adapted to releasably couple to the base of the
first soft tissue anchor.

5. The system of claim 1, wherein the base of the first soft tissue
anchor defines a first section and a second section, the first section
having a first width and the second section having a second width, the
second width being greater than the first width.

6. The system of claim 5, wherein the first section of the base of the
first soft tissue anchor is adapted for securing the first filament to
the first soft tissue anchor.

7. The system of claim 5, wherein the first section of the base of the
first soft tissue anchor defines a recessed portion of the base.

8. The system of claim 1, wherein the apex of the first soft tissue
anchor is adapted to penetrate soft tissue.

9. The system of claim 8, wherein the apex of the first soft tissue
anchor extends from the first end portion of the suburethral support.

10. The system of claim 8, wherein the apex is arrow-head shaped.

11. The system of claim 8, wherein the apex is a sharp tip adapted to
penetrate tissue.

12. The system of claim 8, wherein the plurality of barbs of the first
soft tissue anchor have surfaces directed rearwardly with respect to the
apex of the first soft tissue anchor such that the first soft tissue
anchor substantially resists being pulled back through soft tissue in a
direction opposite to that in which the first soft tissue anchor was
inserted.

13. The system of claim 1, wherein the second soft tissue anchor has an
apex opposite a base and a plurality of barbs adapted for soft tissue
anchoring.

14. A method for treating urinary incontinence by providing support to a
urethra of a patient, the method comprising: making a vaginal incision
for securing a suburethral support under a urethra of a patient, the
suburethral support being formed of a mesh material, defining a
substantially rectangular outer profile, and having a first end portion
and a second end portion; passing a first filament through an aperture of
a first introducer, the first filament being connected to a base of a
first soft tissue anchor, the first soft tissue anchor including a
plurality of barbs and an apex opposite the base, the first introducer
having an elongate shaft and a handle, the elongate shaft having a distal
portion with a terminal end and a proximal portion coupled to the handle,
the distal portion of the elongate shaft defining the aperture adapted to
receive the first filament; releasably coupling the first soft tissue
anchor with the first introducer by advancing the first introducer over
the first filament until the first soft tissue anchor engages the
terminal end of the distal portion of the elongate shaft such that the
apex of the first soft tissue anchor extends distal to the terminal end
of the introducer; inserting the first soft tissue anchor through the
vaginal incision and penetrating soft tissue by pressing the apex of the
first soft tissue anchor into the soft tissue on a first side of the
urethra using the first introducer.

15. The method of claim 14, further comprising attaching the first
filament around a portion of the base of the first soft tissue anchor.

16. The method of claim 14, further comprising pulling the first filament
to generate tension and bringing the base of the first soft tissue anchor
against the terminal end of the elongate shaft of the first introducer.

17. The method of claim 16, further comprising decoupling the first soft
tissue anchor from the first introducer by releasing the tension on the
first filament and retracting the first introducer.

18. The method of claim 14, further comprising repositioning the first
soft tissue anchor by one of advancing and retracting the first
introducer in cooperation with the first soft tissue anchor.

19. The method of claim 14, further comprising passing a second filament
through one of the aperture in the first introducer or an aperture of a
second introducer, the second filament being connected to a base of a
second soft tissue anchor, the second soft tissue anchor including a
plurality of barbs and an apex opposite the base.

Description:

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of pending U.S. application Ser.
No. 13/149,994 filed Jun. 1, 2011, and entitled SYSTEM FOR INTRODUCING
SOFT TISSUE ANCHORS, which is a continuation of U.S. application Ser. No.
12/837,601 filed Jul. 16, 2010, now U.S. Pat. No. 8,007,430, and entitled
APPARATUS AND METHOD FOR TREATING FEMALE URINARY INCONTINENCE, which is a
continuation of U.S. application Ser. No. 11/199,061 filed Aug. 8, 2005,
now U.S. Pat. No. 7,789,821, which in turn is a continuation of U.S.
application Ser. No. 10/398,992, filed Apr. 11, 2003, now U.S. Pat. No.
6,960,160, which in turn is a national stage application under 35 U.S.C.
371 of International Application No. PCT/GB01/04554, filed Oct. 12, 2001,
which in turn claims priority of Great Britain Application No.
GB0025068.8, filed Oct. 12, 2000, the contents of each of which are
incorporated by reference herein for all purposes.

[0002] This invention relates to an apparatus and method for treating
female urinary incontinence and, in particular, to a surgical implant
having a sling that passes under the urethra in use and supports the
urethra to alleviate incontinence, along with related apparatus and
methods for inserting the surgical implant in the body.

[0003] Urinary incontinence affects a large number of women and,
consequently, various approaches have been developed to treat female
urinary incontinence. Those skilled in the art will be familiar with
approaches ranging from pelvic floor exercises to surgical techniques
such as Burch colposuspension and Stamey-type endoscopic procedures in
which the sutures are placed so as to elevate the bladder neck.

[0004] This invention is particularly directed to improvement of a known
procedure in which a sling is positioned loosely under the urethra,
commonly known as TVT (tension free vaginal tape) and described, for
example, in International Patent Applications No. WO97/13465 and
WO97/06567. It is generally understood that this treatment alleviates
urinary incontinence by occluding the mid-urethra (for example at a time
of raised abdominal pressure by coughing or the like).

[0005] The sling is provided in the body using two large curved needles
which are provided at each end of the sling, which sling comprises a long
mesh or tape. Each of the needles is carried on an insertion tool (which
is basically a handle facilitating manipulation of the needles). The mesh
or tape is usually made of knitted polypropylene (such as Prolene®).
The mesh or tape is generally covered with a plastics sleeve or
polyethene envelope to aid smooth insertion, the mesh or tape having
rough surfaces to aid retention in the body.

[0006] An incision is made in the anterior vaginal wall and the first of
the needles is passed through the incision, past one side of the urethra,
behind the pubic bone, through the rectus sheath and out through the
lower anterior abdominal wall. Likewise, the second needle is passed
through the incision, past the other side of the urethra, behind the
pubic bone, through the rectus sheath and out through the lower abdominal
wall. The needles are separated from their respective insertion tools and
also from the mesh or tape such that only the tape and its plastics
sleeve are left in the body, passing from a first exit point in the lower
abdominal wall, through the rectus sheath, behind the pubic bone, under
the urethra, back behind the pubic bone, back through the rectus sheath
and out through a second exit point in the lower abdominal wall.

[0007] The plastics sleeve is then removed from the tape and the tape
adjusted to a suitable tension (such that the tape provides a sling that
passes loosely under the urethra, as described above) by manoeuvring the
free ends of the tape outside the exit points in the lower abdominal wall
whilst the urethra is held using a rigid catheter inserted therein. The
tape is then cut such that it just falls short of protruding from the
exit points in the lower abdominal wall. The exit points and the incision
in the upper vaginal wall are then closed by sutures. The tape is held in
position by virtue of friction between the tape's rough edges and the
surrounding body tissue (such as the rectus sheath and the body tissue
behind the pubic bone) and subsequent natural adhesion of the tape with
the body tissue as it re-grows around the mesh material. Whilst highly
effective in treating urinary incontinence, this procedure has a number
of problems. One such problem is that the needles used for inserting the
tape are comparatively large, with the needles having, for example, a
diameter of around 5-6 mm and a length of around 200 mm. As well as
causing concern for patients viewing such needles before or during the
procedure (which is carried out under local anaesthetic), this can also
lead to a high vascular injury rate.

[0008] Similarly, the requirement that the needles exit the lower
abdominal wall is disadvantageous due to the trauma to the patient in
this area and pain of such abdominal wounds. A further disadvantage is
that the tape comprises a relatively large foreign body mass to be
retained within the patient and this can lead to related inflammation,
infection translocation, erosion, fistula and such like.

[0009] Similarly, the nature of the large needles and tape, along with the
tools required to insert these in the body, lead to the procedure having
a relatively high cost.

[0010] According to a first aspect of the present invention there is
provided a surgical implant for supporting the urethra, the implant
comprising: a suburethral support suspended between at least two soft
tissue anchors attached at either side of the suburethral support, each
soft tissue anchor having retaining means for retaining each anchor in
tissue and suspending means for suspending each side of the suburethral
support from a soft tissue anchor such that the suburethral support
passes under the urethra in use.

[0011] Preferably the retaining means of the soft tissue anchor is capable
of being inserted into soft tissue or fascia from an incision in the
upper vaginal wall without the need to penetrate the lower abdominal
wall.

[0012] In one embodiment the soft tissue anchor is insertable into the
rectus sheath of the human or animal body to anchor suspending means to
the soft tissue, the suspending means being attached to the soft tissue
anchor and the soft tissue anchor having retaining means adapted to
prevent retraction of the anchor from the rectus sheath in a direction
opposite to that of insertion of the anchor into the tissue.

[0013] Preferably the soft tissue anchor comprises a central portion and
the retaining means includes at least one wing section, the wing section
being mounted on a first end of the central portion by resilient hinge
means such that the wing section is moveable between an open, resting
position and a deflected position such that in use, when the soft tissue
anchor device is inserted into the tissue the wing section is pushed or
held towards the central portion to a deflected position to permit entry
of the soft tissue anchor into the tissue and through the rectus sheath,
wherein the wing section returns to its open or resting position and
prevents the soft tissue being removed.

[0014] Preferably the resilient hinge means allows the wing section to
return to its resting position from its deflected position following
penetration of the soft tissue anchor through the rectus sheath such that
the wings of the soft tissue anchor once pushed through the rectus sheath
can rest on the surface of the rectus sheath fascia opposite to the
surface through which the soft tissue anchor is inserted and thus the
soft tissue anchor cannot be retracted.

[0015] Preferably the resilient hinge means is capable of preventing the
wing section being moved to a position greater than substantially
perpendicular to the central portion.

[0016] Preferably the central portion of the soft tissue anchor comprises
a hollow passage which extends from a first end of the central portion to
a second opposite end of the central portion.

[0017] Preferably an introducing tool can be placed into the hollow
passage such that the introducing tool extends through the central
portion the soft tissue anchor such that the introducing tool extends to
a point beyond the first end of the central portion.

[0019] More preferably the soft tissue anchor comprises four wing sections
arranged radially around the first end of the central portion.

[0020] Preferably the soft tissue anchor in addition to comprising a
central portion and a wing section also comprises at least one stud
element arranged radially around the first end of the central portion,
the stud having an inclined face in the opposite direction to that in
which the soft tissue anchor is inserted to aid separation of the tissue
during entry of the soft tissue anchor enabling easier passage of the
soft tissue anchor through the soft tissue.

[0021] Preferably the soft tissue anchor does not comprise a sharp point.

[0022] In an alternative embodiment the soft tissue anchor is capable of
anchoring in the retropubic tissue space without penetrating the rectus
sheath.

[0024] A soft tissue anchor according to this embodiment comprises a
central portion and the retaining means includes a plurality of
projections the projections extending radially from the central portion
along a substantial portion of the length of the central portion allowing
fixation at a plurality of layers. Preferably the projections extend
radially from the central portion at an angle inclined toward the second
end of the central portion.

[0025] Preferably the projections are of a shape that they are able to
provide additive traction to the soft tissue anchor and allow it to grip
fibro-fatty soft tissue and blood vessels of the para-uretheral tunnel
below the level of the rectus sheath.

[0026] In yet a further embodiment the soft tissue anchor may comprise a
substantially flat head the bottom surface nearest the suspending means
of the flat head providing the retaining means which, in use is held in
the rectus sheath.

[0027] In a further embodiment the soft tissue anchor may comprise a sharp
point allowing it to pierce or penetrate the rectus sheath, and retaining
means comprising a surface or protrusion directed rearwardly with respect
to the sharp point which does not cause the soft tissue to part and thus
prevents the soft tissue anchor from being pulled back out through the
rectus sheath soft tissue in the direction opposite to that in which it
is inserted into the soft tissue.

[0028] Preferably the sharp point is provided by the apex of a conical
head portion and retaining means are provided by a substantially flat
base of the conical head.

[0029] In any embodiment the soft tissue anchor is comprised of plastics
material.

[0030] Typically the soft tissue anchor is comprised of polypropylene.

[0031] Alternatively the soft tissue anchor is comprised of absorbable
material so as to form temporary fixation in soft tissue.

[0032] The soft tissue anchor may comprise a point formed of absorbable
material including polyglactin, the sharp point thus capable of
facilitating insertion of the anchor, yet being absorbed by the body
later.

[0033] Preferably the soft tissue anchor may be integral with the
suspending means.

[0034] More preferably the soft tissue anchor is integrally formed from
polypropylene or other polymeric material the attachment between the
anchor and the suspending being formed as a single unit.

[0035] An integral construction of the soft tissue anchor and suspending
means has the advantage of simplifying the construction of the soft
tissue anchor and suspending means, which can reduce the possibility of
defective manufacture etc. and reduce costs and the chance of the soft
tissue anchor and suspending means becoming detached once implanted in
the body.

[0036] Alternatively the soft tissue anchor is attached to the suspending
means by a thin metal tube crimped or otherwise attached around the
suspending means and central portion of the soft tissue anchor.

[0037] The suburethral support of the first aspect of the invention passes
under the urethra, loosely supporting the urethra, the suburethral
support being held in position by suspending means attached to each of
its free ends on either side of the urethra, the suspending means being
attached at the opposite end to at least one soft tissue anchor.

[0038] Preferably the suburethral support is comprised of flat polymer
tape.

[0039] Preferably the suburethral support has dimensions sufficient only
to pass around the urethra.

[0040] More preferably the suburethral support has dimensions of length
15-35 mm, width 5-15 mm and thickness 50-350 μm.

[0041] In one embodiment the suburethral support has dimensions of length
25 mm, width 10 mm and thickness 100 μm.

[0042] Preferably the suburethral support has at least two junctions to
attach the suburethral support to the suspending means.

[0043] One problem with the preferred arrangement of a soft tissue anchor
and suspending means for suspending the suburethral support of the
surgical implant of the invention is that it is difficult to predetermine
what length the suspending means must be to position the suburethral
support loosely under the urethra as desired.

[0044] This is because the distance between the rectus sheath in which the
soft tissue anchor is inserted and the urethra varies from patient to
patient.

[0045] Preferably the distance between the soft tissue anchor(s) and the
suburethral support is adjustable.

[0046] More preferably the soft tissue anchor (or anchors) can be
positioned first and the suburethral support then positioned by adjusting
the length of the suspending means.

[0047] Preferably the suburethral support is provided with at least one
attachment tab to which suspending means are releasably or permanently
attached.

[0048] Preferably the suburethral support comprises an attachment tab
comprising a tunnelled element and an aperture, the tunnelled element
being located at each of the free ends of the suburethral support on
either side of the urethra at a position that the suspending means are
capable of being introduced through, the tunnelled element co-operating
with the aperture such that suspending means can be passed through the
tunnelled element and then through the aperture, the aperture being
present on the opposite surface of the suburethral support to that which
contacts the urethra the aperture having an edge capable of co-operating
with a ring element and the ring element being capable of being fitted
around the aperture trapping the suspending means between the ring
element and the edge of the aperture such that the suspending means
remain fixed in an adjusted position wherein the suburethra support
hanging loosely under the urethra.

[0049] Alternatively the attachment tab comprises at least one slot
through which suspending means can be passed, the suspending means being
permanently attached to the slot by tying.

[0050] Alternatively the attachment tab comprises jamming slots that the
suspending means can be permanently attached by being threaded through
the jamming slots such that the suspending means are held in an adjusted
position.

[0051] Alternatively the suburethral support is capable of being suitably
positioned under the urethra by altering the position of the soft tissue
anchors within the body such that at least one soft tissue anchor is
secured in the soft tissue or in the rectus sheath and a subsequent
anchor is inserted into the soft tissue or rectus sheath to a suitable
depth such that the suburethral support hangs loosely under the urethra.

[0052] Alternatively the suspending means may be attached to the
suburethral support by healing such that the suburethra support and/or
suspending means melt and form a join.

[0053] Alternatively the attachment tabs may have closure means for
gripping the suspending means.

[0054] The suspending means may be any means suitable for connecting each
end of the suburethra support to the soft tissue anchor (or respective
soft tissue anchors).

[0055] Preferably the suspending means comprises a plastics strip.

[0056] Preferably the plastics strip has smooth edges.

[0057] Preferably the plastics strip comprises material such as
polypropylene or other suitable non-absorbable or absorbable polymer
tape.

[0058] Preferably the plastics strip is 3-5 mm in width.

[0059] Preferably the plastics material comprises pores which extend
through the plastics material from a first surface of the plastics
material to a second opposite surface of the plastics material said pores
ranging in width across the surface of the plastics material from 50
μm to 200 μm, the pores allowing tissue in-growth to secure the
strip in the body.

[0060] Alternatively the plastics material may comprise pits, that indent
but do not extend through the plastics material, on at least one of the
surfaces of the plastics material, the pits ranging in width from 50
μm to 200 μm, the pits allowing tissue in-growth to secure the
strip in the body.

[0061] Preferably the plastics material comprises pits or pores ranging in
width across the surface of the plastics material from 100 μm to 150
μm.

[0062] Preferably the pits or pores are distributed across the complete
surface of the plastics material.

[0063] Alternatively the pits or pores are distributed only in a
particular portion of the surface of the plastics material.

[0064] Preferably the pits or pores are created by post synthesis
modification of the plastics material.

[0065] More preferably the pits or pores are created by post synthesis
treatment of the plastics material by a laser.

[0066] Alternatively the pits or pores of between 50-200 μm are created
during synthesis of the plastics material by spaces between the waft and
weave of mono-filament or multi-filament yarns when the filaments are
woven to form a mesh.

[0067] Alternatively pits or pores formed during the synthesis of plastics
material are formed by the inter-filament spaces created when
mono-filaments are twisted to create multi-filaments, the multi-filaments
then being woven to form a mesh.

[0068] In an embodiment the suspending means is provided with a plurality
of microgrooves of width between 0.5-7 μm and of depth 0.25-7 μm on
at least one surface of the plastics strip.

[0069] Preferably the microgrooves are 5 μm in width and 5 μm in
depth.

[0070] Preferably the plurality of microgrooves are aligned such that they
are substantially parallel with each other.

[0071] Preferably the plurality of microgrooves are aligned such that they
are separated by ridges which range in size between 1-5 μm in width.

[0072] More preferably the microgrooves are separated by ridges of 5 μm
in width.

[0073] Preferably the ridges are formed by square pillars and the base of
the microgroove is substantially perpendicular to the square pillars.

[0074] Alternatively the ridges are formed by square pillars and the base
of the microgroove is bevelled in relation to the pillars.

[0075] Preferably the microgrooves are present on at least one surface of
the suspending means.

[0076] More preferably the microgrooves are present on a plurality of
surfaces of the suspending means.

[0077] These microgrooves act to orientate and align the proliferating
fibroblasts on the surface of the plastics material and cause axial
alignment of collagen fibres and formation of at least one strong ordered
neoligament.

[0078] The orientation and alignment of the proliferating cells is capable
of adding mechanical strength to the tissue which forms around the
plastics material such that it is more able to support the urethra.

[0079] Preferably the suburethral support of the present invention has
neither pores, pits or grooves to discourage the formation of
peri-urethral adhesions.

[0080] According to a second aspect of the present invention there is
provided a method of supporting the urethra comprising the steps of,
introducing a surgical implant as described above into an incision made
on the upper wall of the vagina, inserting a soft tissue anchor on a
first side of the urethra behind the pubic bone, inserting a second soft
tissue anchor on a second side of the urethra behind the pubic bone, such
that the suburethral support is suspended from the soft tissue anchor
supports the urethra.

[0081] The invention also provides the use of the method of supporting the
urethra in treating urinary incontinence or uterovaginal prolapse.

[0082] In one embodiment of the method the soft tissue anchors are
inserted in the rectus sheath.

[0083] In an alternative embodiment of the method the soft tissue anchors
are inserted in the fibro-fatty soft tissue of the retropubic tissue
space and do not penetrate the rectus sheath.

[0084] The invention also provides an introducing tool comprising an
elongate housing adapted to receive the soft tissue anchor at one end and
a point which is capable of extending through the central portion of a
soft tissue anchor for use in carrying out the method of the invention
such that the introducing tool enables access and placement of the soft
tissue anchor through the rectus sheath or in the fibrous fatty soft
tissue of the para-urethral tunnel from an insertion point in the upper
vaginal wall.

[0085] More preferably the elongate housing is curved or bent, preferably
through an angle of approximately 30°.

[0086] It is desirable such that a sharp point of an anchor not is not
retained in the body that the soft tissue anchor may be inserted using an
introducing tool the introducing tool having a sharp point for
penetrating the soft tissue.

[0087] Preferably an introducing tool comprises a sharp point for piercing
or penetrating soft tissue and carrying means for carrying the soft
tissue anchor to insert the anchor into the tissue such that the soft
tissue anchor device does not require a sharp head and no sharp point is
left in the body.

[0088] The overall size of the soft tissue anchor and introducing tool may
be significantly smaller than that of the needles of the prior art.

[0089] Preferably the introducing tool may have a diameter of around 2 mm
to 4 mm.

[0090] Preferably if the introducing tool is to be used in co-operation
with a soft tissue anchor comprising a plurality of projections extending
radially from the central portion along a substantial portion of the
length of the central portion of the soft tissue anchor, the introducing
tool comprises containment means for radially confining the plurality of
projections extending from the central portion of the soft tissue anchor
during the insertion of the soft tissue anchor.

[0091] Thus, when the soft tissue anchor has been inserted, the tool may
release the retaining means around the soft tissue anchor such that the
projections which have memory are biased to expand radially and grip the
soft tissue.

[0092] The reduced size of the introducing tool in comparison to the
needles used to introduce devices of the prior art can significantly
reduce the vascular injury rate and perceptual problems of the prior art
for a patient.

[0093] Preferably the introducing tool is able or has means for releasably
retaining the soft tissue anchor on the end of the housing.

[0094] During the insertion of a surgical implant to support the urethra
there is a risk of penetration of the bladder wall by the needles during
insertion of the tape.

[0095] This is known to be a problem with the TVT procedure described by
the prior art where the needles are inserted through an incision in the
vagina to thread the tape through the respective punctures in the lower
anterior abdominal wall.

[0096] Following the TVT procedure of the prior art it is therefore
conventional to carry out cystoscopy after the tape has been inserted in
the body to determine whether or not the bladder has been perforated.
This is painful for the patient and also increases the duration of the
operation.

[0097] The reduced size of the tools used for inserting the surgical
implant of the present invention reduce to some degree the risk of the
bladder being perforated during the surgical procedure, however it is
nevertheless desirable to reduce the need for cystoscopy.

[0098] Accordingly at least a part of the surgical implant of the present
invention may be coated or impregnated with a water soluble dye.

[0099] Preferably the soft tissue anchor of the present invention is
impregnated with a water soluble dye.

[0100] Preferably, the water soluble dye is methylene blue.

[0101] It is possible to determine whether or not the bladder of a patient
has been perforated by a surgical implant or instrument when inserting
the surgical implant of the invention into the body, by expelling a small
amount of fluid from the bladder, and determining whether or not this
small amount of fluid contains any dissolved dye.

[0102] Should the bladder be perforated on insertion and placement of the
surgical implant into the body, the dye impregnated into the surgical
implant will dissolve in the fluid contained in the bladder and diffuse
naturally throughout the fluid.

[0103] Thus should dye be present in the fluid, it is very likely that the
bladder has been perforated and cystoscopy should be carried out. If
there is no dye in the fluid, the bladder has not been perforated and the
need for cystoscopy is obviated.

[0104] The soft tissue anchors as described in relation to the implant of
the present invention are capable of use in a variety of situations.

[0114] FIGS. 7A, 7B and 7C are illustrations of a soft tissue anchor for
insertion through the rectus sheath,

[0115] FIGS. 8A, 8B and 8C are sequential illustrations of insertion of a
soft tissue anchor of FIGS. 7A, 7B and 7C.

[0116] FIG. 9 is an illustration of a soft tissue anchor mounted on an
introducing tool,

[0117] FIG. 10 is an illustration of a retropubic soft tissue anchor for
use in the fibro-fatty tissues of the para-urethral tunnel,

[0118] FIG. 11 is an illustration of the placement of a soft tissue anchor
of FIG. 10,

[0119] FIG. 12 is an illustration of an implanting tool and a soft tissue
anchor inserted into the rectus sheath,

[0120] FIG. 13 is an illustration of the surgical implant implanted into
the rectus sheath,

[0121] FIG. 14 is an illustration of the prior art contrasted with the
technique of the present invention,

[0122] FIG. 15 is an illustration of the tool used to insert the surgical
implant, and

[0123] FIG. 16 is an illustration of the surface architecture of the
suspending means.

[0124] Referring to FIG. 1, a surgical implant for treating female urinary
incontinence has a suburethral support 10, suspending means 20 and at
least two soft tissue anchors 30, the suburethral support 10 being
positioned in use, loosely under the urethra. The suburethral support has
a length L of around 25 mm and a width W of around 10 mm such that it
passes around the urethra with a minimum of excess material, although
other similar dimensions would also be suitable. In this example, the
suburethral support 10 is made from flat polymer tape. At each side 11,13
of the suburethral support 10 suspending means 20 are provided which
attach to the suburethral support 10 at a first end 22,24.

[0125] The suspending means 20 are attached at a second end 26 to a
respective soft tissue anchor 30.

[0126] As shown in FIGS. 7A, 7B and 7C the soft tissue anchor 30 of the
embodiment described comprises a central portion 32 and four winged
sections 34 which are attached to the central portion at a first end 38
by resilient hinge means 36 and radially extend from the central portion
32 such that when viewed from the front the anchor device resembles a
cross.

[0127] As shown in FIG. 8A the wing sections 34 of the soft tissue anchor
30 having a resting position in which they are inclined towards the rear
40 of the central portion 32 at an angle of around 45°. In FIG. 8B
during penetration of the anchor through tissue (the point 60 of the
introducing tool enabling the soft tissue anchor to be pushed through the
tissue and rectus sheath 120) the wing sections 34 of the soft tissue
element 30 may adopt a deflected position which means the penetration of
the soft tissue anchor through the tissue and rectus sheath 120 is more
effective.

[0128] As shown in FIG. 8c once the rectus sheath 120 has been pierced the
resilient hinge means 36 cause the wing sections 34 to return to their
resting position.

[0129] Movement of the soft tissue anchor in a direction opposite to which
it was introduced into the soft tissue causes the wing section to be
deflected until an endstop 46 is reached which prevents the wing sections
34 moving beyond a point substantially perpendicular to the central
portion 32 and prevents retraction of the soft tissue anchor 30 from the
soft tissue.

[0130] The soft tissue anchor 30 further comprises a hollow portion 48
which extends from the first end 38 to the second rear end 40 of the
central portion 32 through which an introducing tool 50 may be placed.

[0131] The introducing tool 50 extends through the hollow portion 48 such
that it extends as a sharp point 60 from the first end 38 of the soft
tissue anchor 30 such that the sharp point 60 allows penetration of the
tissue by the soft tissue anchor 30.

[0132] Stud like projections 42 which extend radially from the central
portion 32 are angled such that they extend further radially from the
central portion 32 as they extend towards the rear 40 of the central
portion 32, this inclination allowing the soft tissue anchor 30 to pass
more easily into the soft tissue.

[0133] A recessed portion 44 is positioned toward the rear end 40 of the
central portion 32 to facilitate attachment of the suspending means 20 to
the soft tissue anchor 30.

[0134] The suspending means 30 may be respectively attached to the soft
tissue anchor 30 at this recessed point 44 by crimping a tube around the
suspending means 20 to fix the suspending means 20 to the soft tissue
anchor 30.

[0135] In the embodiment shown the soft tissue anchor may be suitably
positioned in the rectus sheath 120 using an introducing tool 50. As
shown in FIG. 15 the tool 50 comprises a handle 52 and elongate body 54.
The elongate body 54 is curved through an angle of approximately
30° to facilitate positioning of the soft tissue anchor 30 in the
rectus sheath or surrounding soft tissue of the human body from an
incision in the upper wall of the vagina (as described below). The soft
tissue anchor 30 is located on the elongate body at a narrowed portion 58
of the introducing tool such that the soft tissue anchor is held in place
by an abutment 56 such that the narrowed portion 58 may extend through
the hollow portion 48 of the soft tissue anchor 30 such that the point 60
of the insertion tool 50 protrudes from the first end 38 of the soft
tissue anchor and allows the soft tissue anchor to be inserted into the
human body through the soft tissues and more specifically through the
rectus sheath 120 during the placement of the soft tissue anchor.

[0136] The placement of the soft tissue anchor 30 on the insertion tool 50
is shown in FIGS. 8B and 8C, which shows the soft tissue anchor 30 being
pushed through soft tissue fascia, such as the rectus sheath 120. Once
the soft tissue anchor has penetrated the rectus sheath fascia 120, as
shown in FIG. 8B, the introducing tool 50 can be withdrawn, as shown in
FIG. 8c, leaving the soft tissue anchor 30 in place.

[0137] As shown in FIG. 9 the soft tissue anchor may alternatively be
comprised of a central portion 70 and a plurality of projections 72 the
projections extending radially from the central portion 70 and arranged
along a substantial portion of the length of the central portion 70. The
projections 72 may be of any shape such that they provide resistance
within the fibro-fatty soft tissue and blood tissues of the para-urethral
tunnel in the direction opposite to that in which the soft tissue anchor
is introduced.

[0138] This resistance is also provided by the multiple layers, typically
between 5-10 layers of projections 72 which extend from the central
portion 70.

[0139] Using these multiple layers of projections 72 it is not necessary
to insert the soft tissue anchor through the rectus sheath 120. Instead
the soft tissue anchor should be positioned as high in the retropubic
space as possible in the fibro-fatty soft tissue.

[0140] In the embodiment of the soft tissue anchor comprising multiple
layers of projections 72 which resembles a christmas tree, as shown in
FIG. 10, the introducing tool comprises a collar which releasably retains
the projections during insertion into the retropubic space. The collar
may comprise a semi-sharp bevelled needle. Following insertion of the
christmas tree like anchor into the fibro-fatty soft tissue of the
retropubic space the introducing tool is withdrawn removing the collar
from around the plurality of projections 72 of the soft tissue anchor,
which due to their memory expand outwards from the central portion 70 and
grip the fibro-fatty soft tissue of the retropubic space at multiple
layers. The collar of the introducing tool which extends around the soft
tissue may contain a cross-sectional opening such that once the tool is
withdrawn the collar may be removed from the surgical implant by passing
the implant through the cross-sectional opening.

[0141] Accordingly the invention also provides an introducing tool for use
in inserting the soft tissue anchor.

[0142] Suspending means 20 attached to the soft tissue anchors are formed
from a strip of plastics material such as polypropylene which is
sufficiently soft to avoid damaging the urethra or surrounding body
tissue and suitably inert such that it can be left in the human body for
a long period of time without causing adverse reactions. Again, other
suitable materials will be apparent to those skilled in the art.

[0143] The polypropylene mesh strip of 3-5 mm in width which forms the
suspending means 20 has smooth edges to avoid adhesion of the soft tissue
to the strip, reducing problems associated with leaving foreign material
in the human body for long periods of time. As shown in FIG. 16 the
polypropylene mesh strip further comprises pores or pits 80 ranging in
width across the surface of the strip from 50 μm to 200 μm, which
extend through the strip from a first surface of the strip 26 to a second
opposite surface 28 of the strip the pores 80 allowing tissue in-growth
to secure the suspending means 20 in the body.

[0144] The pores 80 are created by post synthesis treatment of the
polypropylene mesh material by a laser.

[0145] The polypropylene mesh which forms the suspending means 20 also
comprises microgrooves 82 of width 5 μm and of depth 5 μm on the
surfaces of the polypropylene mesh.

[0146] The microgrooves 82 are aligned such that they are substantially
parallel with each other and separated by ridges of around 5 μm in
width.

[0147] The ridges are formed by square pillars the base of the microgroove
being substantially perpendicular to the square pillars or bevelled in
relation to the pillars. The microgrooving 82 being present on both
surfaces of the suspending means to orientate and align the proliferating
fibroblasts on the surface of the plastics material and cause axial
alignment of collagen fibres and formation of at least one strong ordered
neoligament.

[0148] This orientation and alignment of the proliferating cells adding
mechanical strength to the tissue which forms around the plastics
material such that it is more able to support the urethra.

[0149] The suburethral support is not provided with pores, pits or grooves
to discourage the formation of peri-urethral adhesions.

[0150] Once the soft tissue anchors have been suitably positioned in
either the soft tissue of the para-urethral tunnel or through the rectus
sheath 120 the length of the suspending means 20 can be altered such that
the suburethral support 10 hangs loosely under the urethra.

[0151] As shown in FIGS. 2A and 2B, the suspending means 20 are attached
at a first end 22, 24 to the sides 12, 14 of the suburethral support 10,
which extend on either side of the urethra.

[0152] As shown in FIGS. 6A-6C, a preferred method of altering the length
of the suspending means 20 attached to the suburethral support 10
comprises a tunnelled element 13 at each of the free ends 22,24 of the
suburethral support 10 on either side of the urethra. The tunnelled
element 13 extends from the edges of the suburethral support 10 to an
aperture 15, the aperture being present on the opposite surface 16 of the
suburethral support 10 to the surface which contacts the urethra 17, the
aperture 15 having an edge 18 able to co-operate with a ring element 19
such that the ring element which has memory can be pushed onto the edge
18 of the aperture 15 trapping the suspending means 20 between the edge
of the aperture 18 and the ring element 19 thus securing the suburethral
support 10 along a particular desired length of the suspending means 20
such that the suburethra support 10 hangs loosely under the urethra.

[0153]FIG. 5 shows an alternative method of attaching the suspending
means 20 to the suburethral support 10, the suspending means 20 being
threaded through jamming slots 12 such that the suspending means 20 are
permanently attached to the jamming slots 12 by being pulled into the
jamming slots 12 as shown in FIG. 5 such that the suspending means is
held tightly in position.

[0154] Alternatively, the suspending means 20 may be passed through slots
and the suspending means permanently attached to the slots by tying.

[0155] In use, as shown in FIG. 12 the soft tissue anchor 30 is placed on
the introducing tool 50 as described above. An incision 117 is made in
the upper wall 116 of the vagina, as shown in FIG. 11, and the
introducing tool 112 is passed through the incision 117, past one side of
the urethra 118, behind the pubic bone 119 and into the rectus sheath
120. It is apparent to the surgeon when the rectus sheath 120 has been
penetrated as this stage of insertion presents significant resistance.
Once the head 58 of the introducing tool 50 and the soft tissue anchor 30
have passed through the rectus sheath 120, the resistance diminishes and
the surgeon ceases to insert the introducing tool 50.

[0156] The introducing tool 50 is retracted from the body releasing the
soft tissue anchor 30. Due to the wing sections 34 on the central portion
32 of the soft tissue anchor 30, the soft tissue anchor 30 is retained by
the rectus sheath 120 as the introducing tool 50 is retracted. Thus, the
suspending means remains in the body, secured by the soft tissue anchor
which is opposed by the rectus sheath 120.

[0157] This procedure is repeated, with a second soft tissue anchor 30 and
suspending means 20, with the introducing tool 50 being passed through
the incision 117 and past the other side of the urethra 118. Thus, two
suspending means 20 are provided, attached to the rectus sheath 120, one
passing either side of the urethra 118.

[0158] The suspending means 20 are passed through the tunnelled elements
13 of the suburethral support 10, and the suspending means 20 are pulled
through the aperture 15 until the suburethral support 10 is positioned
such that it passes under the urethra 118. The suspending means 20 are
then fixed in place by placing a ring element 19 over the edge 18 of the
aperture 15 such that the suspending means are trapped between the edge
18 and the ring element 19 securing them in place.

[0159] Alternatively as shown in FIG. 5 the suspending means may be fixed
in the attachment tabs by threading them through jamming slots 12 or
tying, as described above. The optimal lengths of the suspending means 20
are such that the suburethral support 10 passes under the urethra 118,
but exerts no pressure on the urethra 118 unless the bladder 121 is
displaced. The optimal positioning of the suburethral support 20 is
roughly as illustrated in FIG. 14. When the bladder is displaced, the
suburethral support 10 aids closure of the urethra 118, thus alleviating
urinary incontinence.

[0160] In this example, a portion of the surgical implant is impregnated
with methylene blue, which is a harmless water soluble dye. At the end of
the procedure a small amount of fluid is expelled from the bladder 121.
Should this fluid contain any dissolved methylene blue, it is very likely
that the bladder has been perforated on placing the soft tissue anchor
30. In this case, cystoscopy should be carried out. If no methylene blue
is present, the need for cystoscopy is advantageously obviated. Other
suitable water-soluble dyes may, of course, be used.

[0161] Referring to FIG. 14, it can be appreciated that the surgical
implant of the present invention, when inserted in the human body, may
extend from the rectus sheath 120, through the paraurethral space 130 on
one side of the urethra 118, around the urethra and back to the rectus
sheath 120 on the other side. In contrast, the prior art device comprises
a tape 200 that also extends through the abdominal wall 127 and
represents a far greater implanted mass.

[0162] Referring to FIG. 11, in use, the further embodiment of soft tissue
anchor illustrated in FIG. 9 for placement in fibro-fatty soft tissue of
the retropubic space is placed on an introducing tool. An incision 117 is
made in the upper wall 116 of the vagina, as shown in FIG. 11, and the
introducing tool 112 is passed through the incision 117, past one side of
the urethra 118, and located in the fibro-fatty soft tissue and blood
vessels of the para-urethral tunnel. In this case the surgeon does not
introduce the soft tissue anchor as far into the body as described
previously and the rectus sheath 120 is not penetrated. Once the soft
tissue anchor has been suitably positioned in the soft tissue the surgeon
ceases to insert the introducing tool and retracts the introducing tool
from the body releasing the projections of the soft tissue anchor 72. The
release of the projections 72 of soft tissue anchor by the introducing
tool allows the projections to grip the soft tissue surrounding the soft
tissue anchor and provide resistance to movement of the soft tissue
anchor in a direction opposite to that which it was inserted.

[0163] This procedure is repeated, with a second soft tissue anchor such
that the projections 72 of the soft tissue anchor also provide resistance
to movement of the soft tissue anchor in a direction opposite to that
which it was inserted the introducing tool being passed through the
incision 117 and past the other side of the urethra 118.

[0164] Thus, two suspending means 20 are provided, which are held in the
soft tissue comprising fibro-fatty tissue and blood vessels.

[0165] As described above the suspending means 20 are passed through the
attachment tabs of the suburethral support 10, and the suburethral
support 10 positioned such that it passes under the urethra 118.

[0166] Again this device contrasts that described by the prior art device
in that it does not extend through the abdominal wall 127 and does not
represent as much implanted mass.

[0167] Various embodiments of the present invention can be envisaged
within the scope of the invention, for example the soft tissue anchor may
comprise a cone or a half cone such that a circular or semi-circular base
is provided as a retaining means to prevent retraction of the soft tissue
anchor in a direction opposite to that in which it is inserted into the
tissue.

[0168] Alternatively the soft tissue anchor may comprises a substantially
flat or disc shaped head. In this case the introducing tool may have a
conical head with a sharp point at its apex and a slot for receiving the
flat or disc shaped head.

[0169] In yet another example, the soft tissue anchor may be formed of two
sections. The upper section, i.e. the portion of the anchor that forms
the sharp point 10, may be made from an absorbable material, such as
polyglactin such that a sharp point is provided for insertion of the
anchor into the body, but this sharp point is later absorbed by the body
so as to eliminate any discomfort or disadvantage caused by a sharp
pointed object being retained inside the body.

[0170] The soft tissue anchor may be made from metal, such as titanium, as
this is a hard material that can easily be formed into the head having
the sharp point at its apex, and is sufficiently malleable to provide a
tube that may be crimped to the suspending means.